to determine the effect of vaginal Isosorbide Mononitrate administration on cervical ripening before induction of labor
Design
This study is a single-blind clinical trial with two parallel group. Samples are randomly divided into control and intervention groups using random number table. The sample size for each group was calculated to be 32 persons. The phase of this clinical trial is 3.
Settings and conduct
This study is performed on primigravida women who referred to the 22 Bahman and Aria hospitals. In the intervention group, 40 mg Isosorbide Mononitrate tablet and in control group one vitamin C tablet as placebo was placed in the posterior vaginal fornix.
After 12 hours, If Bishop score is <6, the isosorbide mononitrate vaginal tablets will be used again and Bishop scoreis re-measured 12 hours later. After the second visit, patients are induced with oxytocin.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
primigravida mothers with gestational age over 40 weeks; singleton pregnancy;
fetus in a Cephalic presentation presentation with a Bishop score< 4
Exclusion criteria:
Previous scar on the uterus; polyhydramnios, blood pressre> 160/ 110;
proteinuria ≥1; history of intolerance to isosorbide mononitrate; candidates for cesarean section
Intervention groups
The intervention group will be prescribed , 40 mg Isosorbide Mononitrate tablet (manufactured by Arya pharmaceutical company) and control group received one vitamin C tablet (manufactured by dr.abidi pharmaceutical company).
Main outcome variables
changes in Bishop score; duration of hospitalization to active phase (3-4 cm dilatation); side effects of drug (palpitations and headache in mother); delivery method (natural or cesarean section)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191018045150N1
Registration date:2020-04-27, 1399/02/08
Registration timing:registered_while_recruiting
Last update:2020-04-27, 1399/02/08
Update count:0
Registration date
2020-04-27, 1399/02/08
Registrant information
Name
samane raffe
Name of organization / entity
Islamic azad university of mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3890 9438
Email address
akbari-mo@mashhad.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vaginal Isosorbide Mononitrate Administration on Cervical Ripening before Induction of Labor in primigravida
Public title
The Effect of Vaginal Isosorbide Mononitrate Administration on Cervical Ripening before Induction of Labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primigravida mother who have gestational age over 40 weeks.
primigravida mother who have singleton pregnancy.
primigravida mother who have fetus in a Cephalic presentation with a Bishop score < 4.
Exclusion criteria:
Full term Primigravida who have Previous scar on the uterus.
Full term Primigravida who have polyhydramnios
Full term Primigravida who have blood pressre> 160/ 110
Full term Primigravida who have proteinuria ≥ 1
Primigravida who have a history of intolerance to isosorbide mononitrate
Primigravida who are candidates for cesarean section
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method and random number table have been used to assign individuals to groups. In this method, a random point(a number) is first selected and then the numbers in the right-to-left and top-down are read as a single digit. Intervention group with isosorbide was assigned with 0, 1, 2, 3 and 4 numbers, and 5, 6, 7, 8 and 9 numbers were assigned to control group with placebo.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this way, since both the drug and the placebo are used, the participant does not know which of the two control or intervention groups belong to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Mashhad
Street address
Shahinfar Medical School, Shahinfar street, Imam Khomeini street
City
mashhad
Province
Razavi Khorasan
Postal code
9146978831
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.IAU.MSHD.REC.1396.142
Health conditions studied
1
Description of health condition studied
cervical ripening
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
bishop score
Timepoint
Bishop's score is measured before the intervention, 12 hours after the first visit, and every 4 hours after the second visit.
Method of measurement
bishop score scale
Secondary outcomes
1
Description
Mother's blood pressure
Timepoint
Mother's blood pressure is measured before the intervention, 12 hours after the first visit, and every 4 hours after the second visit.
Method of measurement
Mercury Barometer
Intervention groups
1
Description
Intervention group: . In the intervention group, 40 mg Isosorbide Mononitrate tablet(manufactured by Arya pharmaceutical company) was placed in the posterior vaginal fornix. After 12 hours, If bishop score is <6, the isosorbide mononitrate vaginal tablets will be used again and bishop score is re-measured 12 hours later. After the second visit, patients are induced with oxytocin.
Category
Treatment - Drugs
2
Description
Control group: In the control group, a vitamin c tablet(manufactured by dr.abidi pharmaceutical company) was placed in the posterior vaginal fornix. After 12 hours, If bishop score is <6, the vitamin c vaginal tablets will be used again and bishop score is re-measured 12 hours later. After the second visit, patients are induced with oxytocin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Aria hospital, 22 Bahman hospital
Full name of responsible person
samane raffe
Street address
No. 18, Ladan 7, Laden Boulevard,
City
Mashhad
Province
Razavi Khorasan
Postal code
9146978831
Phone
+98 51 3890 9438
Email
akbari-mo@mashhad.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Mashhad
Full name of responsible person
abtahi saeed
Street address
Shahinfar Medical School, Shahinfar street, Imam Khomeini street
City
mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 0041
Email
akbari-mo@mashhad.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Mashhad
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic azad university of mashhad
Full name of responsible person
Samane Raffe
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.18, 7 Ladan , Ladan blvd, mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9146978831
Phone
+98 51 3890 9438
Fax
Email
akbari-mo@mashhad.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Mashhad
Full name of responsible person
zarif najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahinfar Medical School, Shahinfar street, Imam Khomeini street
City
mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
00095132250041
Email
akbari-mo@mashhad.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Mashhad
Full name of responsible person
samane
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 18, Ladan 7, Ladan Boulevard
City
mashhad
Province
Razavi Khorasan
Postal code
9146978831
Phone
+98 51 3890 9438
Email
akbari-mo@mashhad.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All individual data and study protocols can be shared after unidentifiable individuals.
When the data will become available and for how long
Start access period 4 months after printing results
To whom data/document is available
Our data will only be available to researchers working in Academic and scientific institutions
Under which criteria data/document could be used
The use of data should be done with the permission of Mashhad Azad University Research Assistant
From where data/document is obtainable
Vice chancellor for research, Mashhad Azad University, address: http://mshdiau.ac.ir/moavenathaa/vice-chancellor-of-research
What processes are involved for a request to access data/document
Firstly, the request should be sent to the Vice Chancellor for Research of Mashhad Azad University. After obtaining a license, a transcript of the request will be sent to the person responsible for the study and data will be sent via email